Field of the Invention
The invention relates to a 3D container (D for dimension), comprising a rigid frame, a deformable receptacle, and a functional means for treatment of the contents, including an internal element that is located inside the container, especially designed for shipping, storage or treatment of biopharmaceutical fluids. The invention also relates to a unit that comprises such a container and a rigid support that can ensure that it is held.
Description of the Related Art
Flexible pouches for medical use that have two large flexible walls joined at their periphery have been known for a long time. Such pouches, once expanded, remain relatively thin, which justifies the fact that they are often called “pillow” pouches or “2D” pouches (D meaning dimension). Such a small-capacity 2D pouch for individual and one-time use is described according to a particular embodiment in the document U.S. Pat. No. 4,559,053. In this embodiment, the pouch comprises two foldable films made of plastic material and a semi-rigid frame that has a central opening, whereby the two films are welded on the two large surfaces of the semi-rigid frame, through whose wall passes the input/output ports. The invention does not relate to the 2D containers or pouches.
The document FR-A-2 781 202 describes a container that has two large walls and two side gussets. Each gusset comprises two small walls that are connected to one another by an inside fold, and each small wall is connected to the adjacent large wall by an outside fold. Such a container, once expanded, assumes a three-dimensional shape (cylindrical, prismatic, parallelepipedic, . . . ) and can have a volume of 50 liters and even more, which justifies the fact that it is termed 3D.
In the case of a 3D container that is intended in the biopharmaceutical field to be substituted for a traditional stainless steel tank, it is desirable to transfer functions previously executed in the tank to the flexible container. This problem is not posed in the case of 2D containers or pouches. In addition to the input and output of the contents of the container or components of its contents, these functions are typically mixing, aeration, measuring (collecting) data, and pumping. The execution of such functions requires using devices that comprise one or more elements that are solid and that take up a certain amount of space, with more or less simple or distorted shapes, that may or may not be rigid, stationary or mobile, in particular forming part of the group that comprises the rods, shafts, propellers or mixing elements, aerators, pipes . . . placed in the container itself.
The document US-A-2006/0131765 describes a container that is used as a bioreactor, designed to accommodate contents in the fluid state. This container comprises a flexible or non-rigid part and a rigid part. According to the embodiments, the container is open or closed hermetically, and it comprises one or more input/output ports. The rigid part forms a small plate and comprises a protuberance that is located in the container. The rigid part is used as a support for an internal element for treatment of the contents of the container, such as a mixing element or an aerator. Such an embodiment exhibits the drawback that an internal element that is solid and that takes up a certain amount of space, with a more or less simple or distorted shape (with pointed or sharp-edged contours), rigid or non-rigid, stationary or mobile, can damage the flexible part that is made of plastic film if they come into contact with one another.
The document US-B2-6494613 describes a mixing container that is designed to accommodate contents in the fluid state. This container comprises a flexible bag and a sheath or flexible tube that passes through the wall of the bag hermetically and is housed in the bag. An essentially rigid rod of predetermined shape is placed in the sheath or tube and projects from the bag. It is driven by an engine. Such an embodiment exhibits the drawback of being complex and having limited scope, for example ill-suited in the case of a functional means for treatment of the contents of the container, such as a means for mixing, aeration, measuring (collecting) data, and pumping.
The document US-B2-7249880 describes an embodiment of the same type as the preceding one.
Furthermore, the document US-A-2003/0029982, whose object is a large-capacity (or three-dimensional) flexible container for shipping, storage and distribution of liquids, in this case therapeutic fluids or fluids for other medical applications, describes a system for suspension and a system for support for such a container.
Foldable containers of the type comprising one or more rigid frames and a wall that is attached to this—or these—frames are known (see, for example, the document US-A-2008/0011759). However, such containers are not suitable for being able to constitute 3D containers, sterile for single use, for biopharmaceutical fluids that have to accommodate functional means for treatment of the contents of the container, such as a means for mixing, aeration, measuring (collecting) data, and pumping.
The document DE-A-1 301 970 describes a container that comprises a receptacle that has a flexible side wall that has an open free edge that is deformable so as to be able to be in two extreme states, respectively folded flat on itself and expanded in volume, and one or more rigid frames that are hollow and that comprise a transverse opening that is delimited by a side wall that is closed peripherally on itself with which the open free edge of the side wall is made integral. An upper rigid frame and a lower rigid frame comprise a transverse wall opposite the transverse opening. An intermediate rigid frame comprises two opposite transverse openings. In its transverse wall, the upper rigid frame comprises a filling opening and an air vent. Such a container is not suitable per se for shipping, storage or treatment of biopharmaceutical fluids when it is necessary to provide, in the very container, the presence of one or more elements that are solid and that take up a certain amount of space, with shapes that are more or less simple or distorted (with pointed or sharp-edged contours), that may or may not be rigid, stationary or mobile, in particular forming part of the group that comprises rods, shafts, propellers or mixing elements, aerators, pipes, . . . .
Finally, containers that have a large capacity but that are not suitable in the case of biopharmaceutical fluids and do not provide the presence in the container of one or more elements, such as those that were just mentioned, are known (JP-A-04072187, DE-U-20 2006 003 886 and EP-A-0 559 337).
There is therefore a need for sterile, disposable 3D containers, typically for the biopharmaceutical field, designed to contain biopharmaceutical fluids, which are flexible—at least partially, with large capacities—so as to be able to be substituted in traditionally used rigid tanks and which can integrate functional means for treatment of the contents of the container, for example a means for mixing, aeration, measuring (collecting) data, and pumping. There is a need for 3D containers of this type that also are easy to produce, have an acceptable cost in relation to their use, are easy in their logistical management in particular because of their polyvalence, and finally are free from the risk of damage during storage or shipping because of the presence in the container itself of one or more elements that are solid and that take up a certain amount of space, with more or less simple or distorted shapes (in particular with pointed or sharp-edged contours), rigid or not, stationary or mobile, such as those that are part of the group that comprises rods, shafts, propellers or mixing elements, aerators, pipes, . . . . There is also the requirement that the containers of this design can be presented in several different embodiments that can meet the various needs.